Clinical therapeutics
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Clinical therapeutics · Feb 2015
Multicenter StudyThe shortened infusion time of intravenous ibuprofen, part 2: a multicenter, open-label, surgical surveillance trial to evaluate safety.
The literature and clinical data support the use of intravenous (IV) infusions of ibuprofen to control pain and reduce the opioid requirements associated with surgical pain. According to current guidelines, IV ibuprofen can be administered via a slow IV infusion performed during a 30-minute period. Although recent studies indicate that more rapid infusions may yield additional benefits for patients, the safety of such an approach needs further evaluation. The main purpose of this study was to determine the safety of single and multiple doses of IV ibuprofen (800 mg) administered over 5 to 10 minutes at the induction of anesthesia and after the surgical procedure for the treatment of postoperative pain. ⋯ Our study found that IV ibuprofen infused over 5 to 10 minutes at induction of anesthesia is a safe administration option for surgical patients. ClinicalTrials.gov identifier: NCT01334957.
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Clinical therapeutics · Feb 2015
ReviewSimeprevir and sofosbuvir for treatment of chronic hepatitis C infection.
Chronic hepatitis C infection affects a large proportion of the world's population and can lead to significant morbidity and mortality. The standard of care for treatment of hepatitis C infection has been peginterferon and ribavirin, with or without a first-generation protease inhibitor. In late 2013 and early 2014, sofosbuvir and simeprevir obtained regulatory approval, offering the first possibility for all-oral treatment regimens. We provide a review of the clinical efficacy and safety of sofosbuvir- and simeprevir-containing regimens. ⋯ Results from numerous Phase 3 clinical trials indicate that sofosbuvir- and simeprevir-containing regimens are highly effective and safe for the treatment of chronic hepatitis C infection. The approval of these 2 agents has led to a complete overhaul of published guidelines, with sofosbuvir- and simeprevir-containing regimens included in preferred regimens.
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Clinical therapeutics · Feb 2015
Single- and multiple-dose pharmacokinetics of a hydrocodone bitartrate extended-release tablet formulated with abuse-deterrence technology in healthy, naltrexone-blocked volunteers.
A hydrocodone extended-release (ER) formulation was developed to provide sustained pain relief with twice-daily dosing. Developed using the CIMA abuse-deterrence technology platform (CIMA Labs Inc, Brooklyn Park, Minnesota), this formulation also provides resistance against rapid release of hydrocodone when tablets are comminuted and resistance against dose dumping when tablets are taken with alcohol. Two open-label studies evaluated hydrocodone ER pharmacokinetics (PK) after single- and multiple-dose administration in healthy, naltrexone-blocked subjects. ⋯ The PK profile of hydrocodone ER was qualitatively similar after single- and multiple-dose administration. The steady-state profile demonstrated sustained exposure with limited swing and fluctuation. Single and multiple doses of hydrocodone ER (45 and 90 mg) were generally well tolerated in healthy subjects receiving naltrexone; however, exposure to naltrexone may have confounded the interpretation of safety findings.
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Clinical therapeutics · Jan 2015
Inpatient resource use and cost burden of deep vein thrombosis and pulmonary embolism in the United States.
Venous thromboembolism (VTE), which comprises deep vein thrombosis (DVT) and pulmonary embolism (PE), is associated with significant morbidity and mortality. VTE frequently leads to hospitalization and represents a considerable economic burden to the US health care system. However, little information exists on the duration of hospitalization and associated charges among patients with an admitting or primary diagnosis of DVT or PE. This study assessed the charges associated with hospitalization length of stay in patients with DVT or PE discharged from US hospitals in 2011. ⋯ Hospital stays for DVT and PE represent a substantial cost burden to the US health care system. Health care systems have the potential to reduce the clinical and economic burden of VTE by ensuring that evidence-based, guideline-recommended anticoagulation therapy is adhered to by patients with an initial VTE. Appropriate anticoagulant therapy and continuity of care in these patients may reduce the incidence and frequency of hospital readmissions and VTE-related morbidity and mortality and have a potential effect on health care resources.
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Clinical therapeutics · Jan 2015
Changes in long-acting β-agonist utilization after the FDA's 2010 drug safety communication.
In February 2010, the US Food and Drug Administration (FDA) issued new recommendations for the safe use of long-acting β-agonists (LABAs) in patients with asthma. The objective of this study was to determine the impact of the FDA's 2010 safety advisory on LABA utilization. ⋯ The FDA's 2010 advisory was associated with modest reductions in LABA utilization overall and in ways highlighted in their recommendations.